Investigating the effect of two selected training methods on changes in lipid profile, blood sugar, insulin and the expression of some microRNAs in adolescents with type 1 diabetes.
Design
A clinical trial with two separate and randomized training groups
Settings and conduct
Implementation of two selected training methods separately, one group at home under the supervision of the researcher and the other group in the sports club under the supervision of the researcher.
Participants/Inclusion and exclusion criteria
Age range 12-16, no history of other underlying diseases, no regular exercise and type 1 diabetic patient diagnosed by a specialist doctor.
Intervention groups
Resistance training group and aerobic training group
Comparison of two selected exercise training protocols on Expression of mir-181 &mir-204 and some metabolic biomarkers of children with Type1 diabetes
Public title
Comparison of two selected exercise training protocols on Expression of mir-181 &mir-204 and some metabolic biomarkers of children with Type1 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children and adolescents with type 1 diabetes
Diagnosed with diabetes for at least one year
No other underlying disease
Children at least 12 and at most 16 years old
Exclusion criteria:
Children and adolescents with type 1 diabetes who engaged in regular exercise training
Age
From 12 years old to 16 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
1- The outcome assessors in the laboratories will not know how the groups are assigned, and the groups are already coded to control the possibility of bias in the results report.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of university of Isfahan
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Approval date
2024-05-01, 1403/02/12
Ethics committee reference number
IR.UI.REC.1403.026
Health conditions studied
1
Description of health condition studied
Type 1 Diabetes
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
Changes in blood sugar levels are measured and reported in mg/dL units.
Timepoint
It is measured at the beginning of the study and after 8 weeks of exercise interventions.
Method of measurement
with a glucometer
2
Description
Changes in blood insulin levels are measured and reported in microunits per milliliter.
Timepoint
It is measured at the beginning of the study and after 8 weeks of exercise interventions.
Method of measurement
Enzyme-linked immunosorbent assay method.
3
Description
Changes in microRNA-181 levels per fold changes are measured and reported.
Timepoint
It is measured at the beginning of the study and after 8 weeks of exercise interventions.
Method of measurement
It is measured by a real-time polymerase chain reaction device.
4
Description
Changes in microRNA-204 levels per fold changes are measured and reported.
Timepoint
It is measured at the beginning of the study and after 8 weeks of exercise interventions.
Method of measurement
It is measured by a real-time polymerase chain reaction device.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention groups: The first group will perform a selected aerobic exercises for 8 weeks, 2-3 sessions per week with light intensity, and the second group will practice resistance exercises with body weight at home.
Category
Lifestyle
2
Description
Intervention group: Resistance Exercise Training
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University of medical school
Full name of responsible person
Mohammad Ali Shams
Street address
Isfahan, Azadi square, University of Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 913 554 4212
Email
mmdaishs@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Hadi Amiri
Street address
Hezar Jarib
City
Isfahan
Province
Isfehan
Postal code
8174673441
Phone
+98 913 554 4212
Email
mmdaishs@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Shahid Nabian Alley, Hakim Nezami Street
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3627 8066
Email
v.minasian@spr.ui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Consultant, Professor,
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 24, Shahid Nabian Alley, Hakim Nezami Street
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3627 8066
Email
v.minasian@spr.ui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Vazgen Minasian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
No. 24, shahid Nabian Alley, Hakim Nezami Street.
City
Isfahan
Province
Isfehan
Postal code
8175875391
Phone
+98 31 3627 8066
Email
v.minasian@spr.ui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Written consent of the participants was not obtained.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some of the data on the main outcomes can be shared.
When the data will become available and for how long
The period of access will be 1 year after the publication of the results.
To whom data/document is available
University Researchers
Under which criteria data/document could be used
Can only be used for scientific reports.
From where data/document is obtainable
Vazgen Minassian: Dissertation supervisor at Isfahan University.
What processes are involved for a request to access data/document
Applying to the deputy of research and technology of the university and obtaining permission.